Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT07505277

Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome

Led by Dr. Schär AG / SPA · Updated on 2026-04-01

40

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

Sponsors

D

Dr. Schär AG / SPA

Lead Sponsor

B

Bonvicini Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate whether introducing specific functional foods into the diet of individuals at risk of developing metabolic syndrome leads to improvements in key metabolic and oxidative health parameters. The main questions it aims to answer are: Does the consumption of these functional foods reduce post-prandial glycemia? Does daily intake of these formulations improve other health indicators such as body weight, body composition, lipid profile, and oxidative metabolomic markers? The functional food formulations used in this study include: A blend of multifunctional ingredients derived from apple and grape by-products Added prebiotic fibers (inulin) Oat β-glucans Omega-3 fatty acids Participants will: Consume the assigned functional food formulations daily Attend regular clinic visits for physiological measurements and blood tests Undergo assessments of body composition, serum lipids, and serum metabolomics Primary Study Objective: Variation in post-prandial glycemia Secondary Objectives: Reduction in BMI Changes in body composition Changes in serum lipid profile Changes in serum oxidative-related metabolomics

CONDITIONS

Official Title

Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Individuals without metabolic syndrome
  • Abdominal circumference >94 cm for men or >80 cm for women, or BMI between 25 and 34.9 kg/m2
  • At least two of the following: impaired glucose tolerance (≥100 mg/dL), borderline hypertension (systolic 120-139 mmHg, diastolic 80-90 mmHg), or mild hypercholesterolemia (200-239 mg/dL)
  • No long-term medication for diabetes, hypertension, dyslipidemia, hyperuricemia, or other chronic diseases
Not Eligible

You will not qualify if you...

  • Having metabolic syndrome
  • Ongoing pharmacological treatment for metabolic disorders
  • BMI less than 18.5 kg/m2 or greater than 35 kg/m2
  • Glycated hemoglobin (HbA1c) greater than 6%
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bonvicini Clinic

Bolzano, Bolzano, Italy, 39100

Actively Recruiting

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Research Team

P

Prof. Lucio Lucchin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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